Anterior Perineal Plane for Ultra Low Anterior Resection of the Rectum

Colitis, Ulcerative Clinical Trial

— APPEAR  

Official title:

A Multicentre Trial of the Anterior Perineal PlanE for Ultra Low Anterior Resection of the Rectum (The APPEAR Technique) in the Prevention of Permanent Stoma in Benign and Malignant Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00534131
• Other study ID #: 09/H0704/30
• Status: Completed
• Phase: N/A
• Start date: April 1, 2004
• Est. completion date: November 1, 2015

Study information

• Verified date: June 2008
• Source: Queen Mary University of London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Anal sphincter preserving operations are now commonplace for both cancer and non-cancerous rectal diseases. However, this has not always been the case and this development has been facilitated by the invention of circular stapling instruments, which allow the bowel to be reconnected to the anal sphincters, where it would almost be impossible to do so manually. Nevertheless, some patients still require a permanent ostomy, as even with stapling devices ultra low joins of the bowel and sphincter muscles cannot always be performed by a conventional surgery. Therefore, a variety of alternative techniques have been proposed to avoid a permanent ostomy, but these have not become widespread due to the technical difficulty in performing them, their failure to completely eradicate rectal disease, and the damage they inflict upon the anal sphincters resulting in poor bowel function after surgery.

The ideal ultra low sphincter preserving operation should remove the rectal disease entirely, allow the small or large bowel to be safely joined to the anal sphincters under direct vision, and retain the sphincter mechanism in its entirety. We propose such a technique that we term the APPEAR procedure, which approaches the lower third of the rectum via an incision between the scrotum or vagina, and the anal sphincters. This procedure preserves sphincter integrity, and allows either a stapled or manual join of the bowel to the sphincter mechanism, under direct vision. This trial is being conducted as a pilot study, with the procedure only offered to patients for whom a conventional sphincter saving procedure was technically impossible, or contraindicated.

Description:

This study is recruiting patients with distal third rectal pathology, for whom a conventional sphincter saving procedure is contraindicated, or likely to be technically impossible.

Recruited patients will initially undergo trial dissection by conventional sphincter preserving surgical techniques, which if successful will result in patients entering study arm 1.

However, should this not be possible, a trial anterior perineal dissection will be attempted, with patients entered into study arm 2 if perineal dissection is adequate to allow full rectal excision, and preserve sphincter integrity.

If during a trial of anterior perineal dissection it is decided that sphincter preservation is not safe, or will not allow eradication of rectal disease, conventional proctectomy will be performed, with patients entering study arm 3.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: November 1, 2015
• Est. primary completion date: August 1, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• All patients regardless of sex

• Undergoing surgery (with curative intent) to excise the lower third of the rectum who may require a permanent stoma

• Deemed suitable by multidisciplinary team.

Exclusion Criteria:

• Patients under the age of 16

• Patients in whom sphincter preservation has already been deemed inappropriate for medical or surgical reasons (e.g. by an MDT for oncological cure), or in whom surgery has been deemed generally inappropriate.

Related Conditions & MeSH terms

• Colitis
• Colitis, Ischemic
• Colitis, Ulcerative
• Rectal Neoplasms

Intervention

Procedure:
• Standard abdominal approach for rectal excision
Standard abdominal approach for rectal excision
• APPEAR Procedure
Perineal incision to reach the distal rectum
• Proctectomy
standard rectal excision which does not preserve the anal canal

Locations

Country	Name	City	State
United Kingdom	Centre For Academic Surgery, The Royal London Hospital	London	England

Sponsors (1)

Lead Sponsor	Collaborator
Queen Mary University of London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Yield (within each arm of study)		5 years
Primary	Functional assessment (faecal continence)		5 years
Primary	Surgical Safety Assessment		1 year
Primary	Oncological safety assessment - where appropriate		5 years